Diagnostic methods which involve the practical application of a natural phenomenon remain patentable in Australia.

Key takeouts

The patent eligibility of genetic technologies varies considerably between the US and Australia.

Diagnostic methods which involve the practical application of a natural phenomenon are patentable in Australia.

Sequenom, Inc.'s patent for prenatal testing has been found valid and infringed by the Federal Court of Australia.

The Federal Court of Australia has handed down its highly anticipated decision in Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011, finding Sequenom's patent for methods of prenatal testing to be valid and infringed. The decision confirms that diagnostic methods which involve the practical application of a natural phenomenon remain patentable in Australia.

The technology

Sequenom's patent stemmed from the discovery of cell-free fetal DNA (cffDNA) in maternal blood serum and blood plasma by two researchers from Oxford University. The discovery led to the development of non-invasive methods of prenatal testing using maternal blood samples. Prior to the inventors' discovery, prenatal testing involved inserting a needle through the mother's abdomen into the uterus and withdrawing amniotic fluid containing fetal cells.

The case

Claim 1 of Sequenom's Australian patent provides:

A detection method performed on a maternal serum or plasma sample from a pregnant female, which method comprises detecting the presence of a nucleic acid of foetal origin in the sample.

In 2016, Sequenom commenced proceedings in the Federal Court of Australia, alleging that use of the "Harmony" prenatal diagnostic test by Ariosa Diagnostics, Inc., Sonic Healthcare Limited and Clinical Laboratories Pty Ltd infringed certain claims of its patent. The respondents cross-claimed and sought revocation of the patent on various grounds, including that the relevant claims did not define patentable subject matter.

The decision

The respondents alleged that the relevant claims did not define a "manner of manufacture", arguing that they were in substance directed to a mere discovery, namely, that cffDNA is present, and can be detected, in the plasma or serum of a pregnant woman. The respondents further argued that the end result of each claim was not an artificially created state of affairs but, rather, information about the DNA of the fetus. The arguments relied heavily upon the decision of D'Arcy v Myriad Genetics Inc [2015] HCA 35 ('Myriad') in which the High Court of Australia ruled that certain isolated nucleic acids are not patentable subject matter. In that case, the High Court found that the substance of the disputed claims was the information embodied in the sequence of the nucleic acids. Since that information was the same as that which occurs in nature, it was not considered to have been "made" by human action and could not be the subject of a valid claim.

Beach J rejected the respondent's arguments, finding that the relevant claims are within the "plain vanilla" concept of manner of manufacture as outlined in Myriad (at [378]). His Honour emphasised the importance of distinguishing between a product claim (as was considered in Myriad) and a method claim which applies a naturally occurring phenomenon. In that regard, the claims of Sequenom's patent were not directed to a natural phenomenon per se. Rather, they were found to define the practical application of a natural phenomenon, namely, the presence of cffDNA in maternal blood (at [485]). On the question of whether the claims resulted in something "made" by human action, Beach J found that cffDNA could not be detected in maternal blood without human action. Unlike the genetic information embodied in the naturally occurring nucleic acids considered in Myriad or indeed the genetic information encoded by the cffDNA itself, the physical detection of the cffDNA was found to be an outcome that is "made" by human action.

Beach J acknowledged that similar claims had been rejected in the US, but considered the US Court's approach of dissecting the claims into their constituent parts to be contrary to Australian practice (at [522]). His Honour noted that the observations of Linn J in the US decision were perhaps a better reflection of the approach to patentability adopted in Australia following Myriad. In the US decision, Linn J reluctantly concurred with the majority, but lamented the outcome, feeling bound by the Supreme Court's blanket dismissal of diagnostic claims in Mayo Collaborative Services v Prometheus Laboratories, Inc (2012) 566 US 66.

The respondents' other grounds of attack, namely, that the patent was obtained by false suggestion and that its claims lacked an inventive step, utility, sufficiency and fair basis, were all unsuccessful save for claim 26 which was found to lack fair basis.

Consequences

The decision highlights the different approaches taken by US and Australian authorities when it comes to defining patentable subject matter. For companies developing diagnostic technologies, the decision confirms that diagnostic methods which involve the practical application of a naturally occurring phenomenon are patentable in Australia.